The use of fluoride in anticaries drug products, marketed in the U.S., is carried out under the guidance of the FDA's Fluoride Monograph, 21 CFR 355.10 (revised Apr. 1, 2012).
TABLE 1Concentration and Dosage of Stannous Fluoride in Dentifrice/Rinse/Gelproducts according to the Federal Register 21 CFR 355.10DentifricesDentifrices containing 850 to 1,150 ppm theoretical totalfluorine in a gel or paste dosage form.Stannous fluoride 0.351 to 0.474% with an availablefluoride ion concentration = 700 ppm for productscontaining abrasives other than calcium pyrophosphate.Stannous fluoride 0.351 to 0.474% with an availablefluoride ion concentration = 290 ppm for productscontaining the abrasive calcium pyrophosphate.PreventiveStannous fluoride 0.4% in an anhydrous glycerin gel,treatmentmade from anhydrous glycerin and the addition ofgelsuitable thickening agents to adjust viscosity.Treatment rinseStannous fluoride concentrate marketed in a stable formand containing adequate directions for mixing withwater immediately before using to result in a 0.1%aqueous solution.